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U.S. Department of Health and Human Services

Class 1 Device Recall Olympus MAJ891 Forceps/Irrigation Plug (Isolated Type)

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 Class 1 Device Recall Olympus MAJ891 Forceps/Irrigation Plug (Isolated Type)see related information
Date Initiated by FirmDecember 18, 2024
Date PostedJanuary 16, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0905-2025
Recall Event ID 95898
510(K)NumberK912120 
Product Classification Choledochoscope and accessories, flexible/rigid - Product Code FBN
ProductOlympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.
Code Information Model Number: MAJ-891. UDI-DI: 04953170063114. All lot numbers.
Recalling Firm/
Manufacturer
Olympus Corporation of the Americas
3500 Corporate Pkwy
Center Valley PA 18034-8229
For Additional Information ContactCynthia Ow
647-9993203
Manufacturer Reason
for Recall
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
FDA Determined
Cause 2
Labeling design
ActionOlympus notified consignees on about 12/18/2024 via letter. Consignees were instructed to utilize alternative devices to the MAJ-891 according to the provided compatibility table provided, ensure all personnel are completely knowledgeable and thoroughly trained on the content of this letter and the MAJ-891 reprocessing instructions, acknowledge receipt of the letter through the Olympus portal, https://olympusamerica.com/recall, and notify customers if the units have been further distributed. Additionally, Olympus will contact customers to schedule a mutually beneficial time for an Olympus Field Representative to visit each facility and review the contents of this letter and the MAJ-891 reprocessing instructions.
Quantity in Commerce30,140 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FBN
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